Back to resultsIPICK Blocking for TKA With Moderate Flexion Contracture
Primary Purpose
Knee Osteoarthritis, Flexion Contracture of Knees, Anesthesia, Local
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CACB+IPACK
CACB
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring IPACK, knee osteoarthritis, Flexion Contracture of Knees
Eligibility Criteria
Inclusion Criteria:
- The diagnosis was knee osteoarthritis
- The flexion contracture was between 5 and 10 degrees
- ASA grade I-III
Exclusion Criteria:
- Lower extremity neuropathy.
- Contraindications of nerve anesthesia or regional anesthesia.
- unable to cooperate, allergic to the drugs used in this study.
- Non steroidal anti-inflammatory drugs are not tolerated.
- chronic opioid consumption (daily or almost daily use)
Sites / Locations
- The First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
study group
control group
Arm Description
The first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee
The second 20 patients received Continue Adductor Canal Block alone
Outcomes
Primary Outcome Measures
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
extension angle
degree of the extension of knee
extension angle
degree of the extension of knee
extension angle
degree of the extension of knee
extension angle
degree of the extension of knee
extension angle
degree of the extension of knee
extension angle
degree of the extension of knee
Secondary Outcome Measures
range of motion
degree of range of motion from extension to flexion of knee
range of motion
degree of range of motion from extension to flexion of knee
range of motion
degree of range of motion from extension to flexion of knee
range of motion
degree of range of motion from extension to flexion of knee
opioid consumption
total opioid consumption measured by milliliter.
nerve block related symptoms
the incidence of numbness of the nerve related skin
postoperative acute pain
number of cases whose Visual Analog Score for pain was more than 5
Full Information
NCT ID
NCT04603950
First Posted
October 8, 2020
Last Updated
July 22, 2022
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT04603950
Brief Title
IPICK Blocking for TKA With Moderate Flexion Contracture
Official Title
IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °
Detailed Description
From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Flexion Contracture of Knees, Anesthesia, Local
Keywords
IPACK, knee osteoarthritis, Flexion Contracture of Knees
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
The first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
The second 20 patients received Continue Adductor Canal Block alone
Intervention Type
Procedure
Intervention Name(s)
CACB+IPACK
Intervention Description
continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee
Intervention Type
Procedure
Intervention Name(s)
CACB
Intervention Description
continue adductor canal block
Primary Outcome Measure Information:
Title
evaluation of pain
Description
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Time Frame
6 hours after surgery
Title
evaluation of pain
Description
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Time Frame
postoperative day 1
Title
evaluation of pain
Description
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Time Frame
postoperative day 2
Title
evaluation of pain
Description
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Time Frame
postoperative day 3
Title
extension angle
Description
degree of the extension of knee
Time Frame
before surgery
Title
extension angle
Description
degree of the extension of knee
Time Frame
0 hour after surgery
Title
extension angle
Description
degree of the extension of knee
Time Frame
6 hour after surgery
Title
extension angle
Description
degree of the extension of knee
Time Frame
postoperative day 1
Title
extension angle
Description
degree of the extension of knee
Time Frame
postoperative day 2
Title
extension angle
Description
degree of the extension of knee
Time Frame
postoperative day 3
Secondary Outcome Measure Information:
Title
range of motion
Description
degree of range of motion from extension to flexion of knee
Time Frame
6 hour after surgery
Title
range of motion
Description
degree of range of motion from extension to flexion of knee
Time Frame
postoperative day 1
Title
range of motion
Description
degree of range of motion from extension to flexion of knee
Time Frame
postoperative day 2
Title
range of motion
Description
degree of range of motion from extension to flexion of knee
Time Frame
postoperative day 3
Title
opioid consumption
Description
total opioid consumption measured by milliliter.
Time Frame
through hospitalization, an average of 7 days
Title
nerve block related symptoms
Description
the incidence of numbness of the nerve related skin
Time Frame
through hospitalization, an average of 7 days
Title
postoperative acute pain
Description
number of cases whose Visual Analog Score for pain was more than 5
Time Frame
through hospitalization, an average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis was knee osteoarthritis
The flexion contracture was between 5 and 10 degrees
ASA grade I-III
Exclusion Criteria:
Lower extremity neuropathy.
Contraindications of nerve anesthesia or regional anesthesia.
unable to cooperate, allergic to the drugs used in this study.
Non steroidal anti-inflammatory drugs are not tolerated.
chronic opioid consumption (daily or almost daily use)
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IPICK Blocking for TKA With Moderate Flexion Contracture
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